MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; TAP, BONE

Model Number	17109-075
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon was tapping over the 25" blunt guidewire while placing a s2ai screw and noticed a small fragment on the x-ray.Upon further inspection, it was noted the distal tip of the 7.5mm cannulated tap had broken off inside of the ilium.
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
H6.Investigation findings: 3243.Investigation conclusion: 22.Device evaluation: device shows minimal signs of wear.Visual inspection confirms complaint.There is a gash cut at the distal end of the tap.The break is clean and angled at approximately 45 degrees.Additionally, it was observed that another gash cut is flared outward.The third gash has no observable signs of damage.The fragmentation, angle, and bend present on one of the remaining flutes indicate this fracture was likely a result of both high torsional and bending loads.Taps may be used during pedicle preparation to facilitate screw insertion.The cannulation of the tap (through hole) is slid over the guidewire after the site has been dilated to the appropriate diameter.The bone is then tapped to the desired depth.Taps come in 4.5 mm, 5.5mm, 6.5 mm & 7.5 mm and are color coded by diameter.Labeling review: possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.1.Initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.

• Brand Name: INVICTUS
• Common Device Name: TAP, BONE
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 17749457
• Report Number: 2027467-2023-00057
• Device Sequence Number: 17508082
• Product Code: HWX
• UDI-Device Identifier: 00190376192116
• UDI-Public: (01)00190376192116(10)NG121645
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 17109-075
• Device Catalogue Number: 17109-075
• Device Lot Number: NG121645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female